This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).

Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions [ Time Frame: 72 hours after initiation of study medication up to Day 20 ] [ Designated as safety issue: No ]

Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated using Kaplan-Meier method by censoring missing values at the time of last clinical lesion observation.

Secondary Outcome Measures:

Percentage of Participants With Aborted Genital Herpes Lesions [ Time Frame: 72 hours after initiation of study medication up to Day 20 ] [ Designated as safety issue: No ]

Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions.

Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions [ Time Frame: 72 hours after initiation of study medication up to Day 20 ] [ Designated as safety issue: No ]

Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions. The median time was estimated using Kaplan-Meier method.

Time to Resolution of Symptoms Associated With Recurrent Genital Herpes [ Time Frame: 72 hours after initiation of study medication up to Day 20 ] [ Designated as safety issue: No ]

Kaplan-Meier estimated time in hours of the resolution of all symptoms (pain, burning, itching, tingling and tenderness) associated with recurrent genital herpes. Kaplan-Meier method is used to estimate the time to resolution of symptoms.

Number of Patients With a Second Recurrence of Genital Herpes [ Time Frame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes ] [ Designated as safety issue: No ]

Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence.

Time to a Second Recurrence of Genital Herpes [ Time Frame: Up to 6 months after investigator assessed healing of first recurrence of genital herpes ] [ Designated as safety issue: No ]

Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence. Time to a second recurrence of genital herpes was calculated in 2 ways as follows:

From the date of treatment initiation no earlier than the recurrence of genital herpes to the date of onset for the second recurrence, or

From the date of healing of non-aborted lesions or confirmation of aborted lesions to the date of onset for the second recurrence.

Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.

Patients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.

History of at least 4 recurrences of genital herpes in the preceding 12 months

Lesions located on the external genitalia or anogenital region

Willing to discontinue suppressive treatment

Documented positive herpes simplex virus (HSV)

General good health, and history of normal renal function

Exclusion Criteria:

Women of childbearing potential not using approved form of contraceptive

Pregnant or nursing women

History of hypersensitivity to famciclovir, valacyclovir, or acyclovir

Known to be immunosuppressed

Known to have renal dysfunction

Receiving anti-herpes therapy

Known to have other genital tract disorders

Known to have condition which could interfere with drug absorption

Additional protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306787